PlainRecalls
FDA Devices Moderate Class II Terminated

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.

Reported: February 12, 2020 Initiated: December 12, 2019 #Z-1000-2020

Product Description

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.

Reason for Recall

The lot contained two outer pins instead of one outer and one inner pin.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
3
Distribution
Distributed to accounts in California and Ohio.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.. Recalled by Zimmer Biomet, Inc.. Units affected: 3.
Why was this product recalled?
The lot contained two outer pins instead of one outer and one inner pin.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-1000-2020.